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HIVR4P Prevention in Australia
Changes in the HIV Prevention Landscape and Implications for Australia: Insights From HIVR4P

Released: November 20, 2024

Expiration: November 19, 2025

Sharon R. Lewin
Sharon R. Lewin, AO, FRACP, PhD, FAHMS
Activity Information

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Key Takeaways
  • Learning from international challenges with the rollout of long-acting injectables can help future HIV prevention efforts in Australia.

The 5th HIVR4P Conference brought together over 1000 participants from more than 75 countries to advance HIV prevention science and strengthen global collaborations. Held in Lima, Peru, a country facing one of the highest HIV incidences in Latin America, the conference marked the first in-person meeting since the pandemic.

The conference featured 5 tracks: basic science; vaccines and broadly neutralizing antibodies (bNAbs); pre-exposure prophylaxis (PrEP); antiretroviral (ARV)-based prevention; applied and implementation science, and other prevention modalities and cross-cutting issues. The key highlights included the second completed phase III study on lenacapavir for prevention, along with new data on other ARV-based prevention modalities and advances in vaccines that generate bNAbs.  

Follow the Money
A major discussion point at the conference was the critical issue of pricing and access. Sharonann Lynch presented an excellent economic analysis of PrEP pricing, including long-acting (LA) formulations, and argued for the need to set ambitious access targets to appropriately price novel HIV prevention tools. She warned that setting low ambitions leads to higher pricing and ultimately low uptake, as seen with the integrase inhibitor cabotegravir (CAB) LA injectable formulation. She strongly advocated against applying this model to the pricing of lenacapavir PrEP, which had good results in the PURPOSE 2 study. 

Australia has yet to make LA CAB available for HIV prevention through the Pharmaceutical Benefits Scheme (PBS), but several other countries are already reporting their experience with large-scale rollout programs. It is important for clinicians in Australia to learn from the challenges encountered in implementing LA CAB in other high-income countries.

Location, Location, Implementation
The PILLAR study, which implemented LA CAB at 17 clinics across the US, identified challenges such as insufficient staffing, lack of clinic–pharmacy coordination, variable insurance coverage, and issues with scheduling and rescheduling. Implementation strategies identified included creating new staff roles to manage injections, appointing a point person for insurance authorization, offering flexible injection scheduling, and providing transportation or telehealth services. A demonstration of implementing LA CAB at 8 primary care clinics in San Francisco demonstrated that same-day initiation of treatment for 111 clients, with rapid HIV testing (pending HIV viral loads), was feasible. This resulted in 85% on-time injections and 83% 6-month retention.  

…and What About the Elusive HIV Vaccine?
On the vaccine front, there was significant excitement around findings from several recent phase I and II human clinical trials, each testing different approaches to generate bNAbs through “germline targeting,” a strategy which was comprehensively reviewed in a by Eunice Nduati in a plenary talk.

These novel immunogens, designed as either proteins or mRNA, were tested in separate trials. One trial used the BG505 MD39.3 mRNA trimer, while another trial examined BG505 SOSIP.664 protein trimer with a special adjuvant 3M-052-AF+alum. Both trials demonstrated safety and successfully induced broadly neutralizing antibodies, showcasing promising advancements in HIV vaccine development.

In addition, the HVTN 301 phase I trial reported findings from an innovative fractional escalating dose strategy for a nanoparticle HIV vaccine, comparing multiple small doses of vaccines over a short period of time, and aiming to improve immune responses compared to conventional single-dose bolus vaccination. Fractional escalating dosing significantly improved early humoral responses to a germline-targeting vaccine, with 35% of participants developing the desired VRCO1-class B cell responses, compared to 9% in the bolus group. This promising study may have broader applications in vaccine development.

Your Thoughts?
In your clinical practice, what novel PrEP option excites you the most? Get involved in the discussion by posting a comment below.